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U.S. Department of Health and Human Services

Product Classification

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Device biomicroscope, slit-lamp, ac-powered, exempt
Regulation Description AC-powered slitlamp biomicroscope.
Definition This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Physical State Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not used for any screening and automated diagnostic indications.
Technical Method This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Target Area This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePUE
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(K) Exempt
Regulation Number 886.1850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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